Observational Study of Biomarkers of Disease-related Outcomes in Patients With Metastatic Leiomyosarcoma Receiving Chemotherapy

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

Leiomyosarcoma (LMS) is one of the most prevalent soft tissue sarcomas (STS) and can occur in various sites including soft tissue, uterus and retroperitoneal large vessels. Metastatic disease occurs in approximately 50% of patients diagnosed with leiomyosarcoma and prognosis is poor in setting of metastatic disease. A minority of patients benefit from treatment with chemotherapy and early biomarkers of benefit from treatment are lacking. A biomarker of tumor response and patient survival benefit from chemotherapy early in the course of chemotherapy would be of significant impact in treatment planning. Circulating tumor DNA (ctDNA) is present in blood of patients with advanced/metastatic cancer and may serve as biomarker of tumor response to chemotherapy. Blood samples will be collected prior to and during and chemotherapy, and analyzed for ctDNA and for mutations in genes that are associated with increased risk of developing sarcoma. Tumor tissue will be collected and analyzed for changes in genes. Digital images of the sarcoma from CT or MRI scans obtained during treatment will be obtained for advanced radiomic analysis. Study participants will be asked to complete a questionnaire on attitudes and understanding of genetics and genetic testing.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Patients with unresectable or metastatic leiomyosarcoma (LMS). There is no age requirement

• Receiving first-line chemotherapy with doxorubicin or gemcitabine/docetaxel

• Target lesions per RECIST 1.1

• Optional archival tumor tissue including 1 H\&E-stained slide and unstained tumor tissue \[either tissue block containing tumor, or minimum of 4 unstained slides (preferably 8 unstained slides)-fresh frozen sample may also be used in lieu of FFPE sample\] available for study research

Locations
United States
California
Sarcoma Oncology Research Center
RECRUITING
Santa Monica
Massachusetts
Dana- Farber
RECRUITING
Boston
Michigan
University of Michigan Cancer Center
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Ohio State University
RECRUITING
Columbus
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
MD Anderson
RECRUITING
Houston
Other Locations
Australia
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Contact Information
Primary
Scott Schuetze
scotschu@med.umich.edu
734-647-8921
Time Frame
Start Date: 2022-12-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
Enrolled Subjects
Once enrolled subjects will provide Optional Archival Tissue, Optional Fresh tumor for a biopsy and blood collections at baseline, optional day 8 of cycle 1, day 1 of cycles 2-6 and at progression
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov